1 CorPath Systems are not indicated for neuro interventions, nor is it indicated for remote interventions. 1

A Secure Robotics Platform for Remote

Vascular Interventions

Including PCI and Stroke1

Nicholas Kottenstette - R&D Fellow, Steve Blacker – R&D Fellow, Yao Li – Robotics Systems and SW Engineer II, Shenghe Zhao – Advanced Development Engineer, Todd Lander- Principal Engineer, Per Bergman – VP of R&D

Control Systems and The Quest for Autonomy

A Symposium in Honor of Professor Panos J. Antsaklis

10/28/2018

Vascular Interventions

• Vascular Interventions

– Physician gains access to the patient via an introducer sheath

– Physician navigates guide catheter (GC) to opening of vascular region which requires treatment

• Visualization is typically under X-Ray with a fluoroscope in which a radiopaque contrast is injected into the artery or vessel of interest in order to determine treatment options

– Once diagnosis is complete, treatment of the vessel or artery is commenced using additional devices including

• Micro-catheters

• Guide wires to cross a lesion for example

• Balloon catheters to perform angioplasty

• Stent catheters to deliver a stent

2Control Systems and The Quest for Autonomy

An overview for Coronary (PCI)

• PCI

– Access is typically via the radial (wrist) or

femoral artery (groin)

– Most interventions involve a GC which is

seated in the left or right coronary ostium

typically with the aid of a J-wire

– Physician typically steers GW past lesion in

order to allow delivery of RX device

– RX device includes Semi compliant balloons

for angioplasty, {bare metal, medicated}

Stents, High pressure balloons for post

dilatation of Stent.

– During the procedure patient health is

monitored via Hemodynamics

Remote Interventions

PCI

• Time is Heart Muscle

• Reduce time to treatment in surrounding

rural locations in states including:

– Michigan (Ryan D. Madder, M.D., FACC –

Spectrum Health)

– MN (Eleid, Mackram F., M.D – Mayo Clinic)

• From 2001-2006, The number of US PCI

capable hospitals increased by 44%;

however, the increase of population within

one hour only increased by 2%. Leaving

over 20% of the US population being more

than one hour from a PCI capable hospital2.

3Control Systems and The Quest for Autonomy 2- Concannon TW, Nelson J, Goetz J, Griffith, “A percutaneous coronary intervention lab in every hospital?”’ JL Circ Cardiovasc Qual Outcomes. 2012 Jan;5(1):14-20..

Motivation

Stroke: Time to Treatment is Key

• Time is brain – Quantified, Jeffery Saver

– Typical patients suffering large vessel acute

ischemic stroke loose 120 million neurons, 830

billion synapses, and 447 miles of myelinated

fibers per hour.

• Treating stroke via vascular interventions is an

emerging field with improved benefits to

patient outcome (~900k victims per year in

US).

– Lack of proximity to facilities (distance)

– Limited number of specialists

• Only 35k receiving treatment

– Excellent opportunity for robotic intervention to

increase access and reduce time to treatment.

System Overview

4Control Systems and The Quest for Autonomy

CorPath GRX

Key Corpath GRX Features

• Guide Catheter Control & Management– Prismatic and rotational motion of guide catheter allows

the IC to reseat GC during complex cases when GW and/or SC pushes back due to tortuous lesions.

– Enclosing Sheath Allows us to drive the GC distal of the patient.

• Precise monitoring and control of GW and RX devices.

• Bedside Touchscreen– Instructs bedside technologist through device (GW, BSC)

and GC exchanges.

• techniIQTM – Rotate on Retract– When physicians retracts a GW due to traveling off a the

main path down a child vessel, the Robodrive rotates the GW in order to adjust the tips heading and get back on the main path.

• Radiation Shield & Power Vision Monitor– IC remains seated at console with capacitive JS

interlocking system without 25 lb of lead in order to focus on treating patient.

Permanent magnet synchronous motor (PMSM) Control

PMSM is a motor in which the rotor consists of np in {1, 2, …} pole pairs and stator w/ m in {2, 3} phases.

Assume rotor is cylindrical so the stator inductances, L, are constant in the Direct Quadrature (DQ) frame.

Define electrical angle 𝜃𝑒 = 𝑛𝑝𝜃, torque constant K > 0

Park Transform: 𝑓𝑑𝑓𝑞

=cos 𝑛𝑝𝜃 sin 𝑛𝑝𝜃

− sin 𝑛𝑝𝜃 cos 𝑛𝑝𝜃

𝑓𝛼𝑓𝛽

Therefore, 𝑓𝛼𝑓𝛽

=cos 𝑛𝑝𝜃 − sin 𝑛𝑝𝜃

sin 𝑛𝑝𝜃 cos 𝑛𝑝𝜃

𝑓𝑑𝑓𝑞

Clarke Transform: 𝑓𝛼𝑓𝛽

=

2

3−

1

3−

1

3

01

3

−1

3

𝑓𝑎𝑓𝑏𝑓𝑐

,

𝑓𝑎𝑓𝑏𝑓𝑐

=

1 0

−1

2

3

2

−1

2−

3

2

𝑓𝛼𝑓𝛽

Define: ‘effective Q v’: 𝑣𝑞 = 𝑣𝑞 − 𝐾𝜔

Define: DeQ voltage: 𝑣DQ = 𝑣𝑑 𝑣𝑞

Denote the DQ current as: 𝑖DQ = 𝑖𝑑 𝑖𝑞

Recall skew symmetric matrix as 𝑆 =0 1−1 0

in which 𝑆 = −𝑆T

5Petrovic, V., R. Ortega, and A.M. Stankovic, Interconnection and damping assignment approach to control of PM synchronous motors. IEEE Transactions on Control Systems Technology, 2001. 9(6): p. 811-820..

A Closed Loop Control Law of PMSMs Which Is Asymptotically Stable

PMSM Model:

𝐿 ሶiDQ = ҧ𝑣DQ − 𝑅𝑖DQ + 𝑛𝑃𝜔𝐿𝑆𝑖DQ

𝐽 ሶ𝜔 = 𝐾𝑖𝑞 − 𝜏𝑙 − 𝐵𝜔 − 𝐾𝑑4sin 4𝑛𝑝𝜃 − 𝜏𝑓 tanh𝜋𝜔

𝜔𝑓

DQ Control Law for PI Control of PMSMs𝑒DQ 𝑡 = 𝑖DQ−r − 𝑖DQሶiDQ−I 𝑡 = 𝑘DQ−I𝑒DQ 𝑡

𝑖DQ−c 𝑡 = 𝑘DQ−P𝑒DQ 𝑡 + 𝑖DQ−I 𝑡

𝑣DQ 𝑡 = 𝑅𝑖DQ−c 𝑡 .

The proof for stability involves passivity theory showing: i) that the mapping from the PMSM voltage input 𝑣DQ to the PMSM current output 𝑖𝐷𝑄 is strictly output passive; ii) the PI control law (s.t. 𝑘DQ−P > 0 and 𝑘DQ−I ≥ 0) is strictly input passive; and iii) from the passivity theorem the resulting system is asymptotically stable.

Passivity Based Control of PSMS

PCI

• Time is Heart Muscle

• Reduce time to treatment in surrounding

rural locations in states including:

– Michigan (Ryan D. Madder, M.D., FACC –

Spectrum Health)

– MN (Eleid, Mackram F., M.D – Mayo Clinic)

• From 2001-2006, The number of US PCI

capable hospitals increased by 44%;

however, the increase of population within

one hour only increased by 2%. Leaving

over 20% of the US population being more

than one hour from a PCI capable hospital2.

6Control Systems and The Quest for Autonomy 2- Concannon TW, Nelson J, Goetz J, Griffith, “A percutaneous coronary intervention lab in every hospital?”’ JL Circ Cardiovasc Qual Outcomes. 2012 Jan;5(1):14-20..

Motivation

Stroke: Time to Treatment is Key

• Time is brain – Quantified, Jeffery Saver

– Typical patients suffering large vessel acute

ischemic stroke loose 120 million neurons, 830

billion synapses, and 447 miles of myelinated

fibers per hour.

• Treating stroke via vascular interventions is an

emerging field with improved benefits to

patient outcome (~900k victims per year in

US).

– Lack of proximity to facilities (distance)

– Limited number of specialists

• Only 35k receiving treatment

– Excellent opportunity for robotic intervention to

increase access and reduce time to treatment.

System Overview

7Control Systems and The Quest for Autonomy

Remote Architecture – C2 Corpath GRX, Navigation, and Patient Monitoring

Remote Cath Lab

• Firewall with Real-Time Hardware Enabled

IPSEC VPN (Gigabit, low latency)

• Simulink Real-Time speedgoat target

– USB 3.0 based Image capture and

compression of fluoro via. Magewell

– PTP synchronization to GPS referenced

Grandmaster Clock via ETH3

– FPGA based IO for JS Console

– High Speed CAN interface to GRX Robodrive

– Image and C2 comm via ETH2 with IC

• Host machine

– Console GUI for C2 via ETH1 to speedgoat

– USB 3.0 based Image capture and

compression of Hemodynamics

System Overview

8Control Systems and The Quest for Autonomy

Remote Architecture – C2

Intervention Cardiologist (IC) Office

• Firewall with Real-Time Hardware Enabled

IPSEC VPN (Gigabit, low latency)

• Simulink Real-Time speedgoat target

– Image decompression and display of fluoro

– PTP synchronization to GPS referenced

Grandmaster Clock via ETH3

– FPGA based IO for JS Console

– Image and C2 comm. via ETH2 with RCL

• Host machine

– Console GUI for C2 via ETH1 to speedgoat

– Image decompression and display of

Hemodynamics

– Capacative touchscreen for improved

immersion and access

Remote Technology Development

9Control Systems and The Quest for Autonomy

Achievements & Planned Milestones

Videos & Presentations

• TCT 2018 Presentations

• TCT 2018 Live Cases

• Corindus Channel

For Fun : Deadlock Free Petri Net For IC and RCL C2

Control Systems and The Quest for Autonomy 10

RCL-IC Console Petri Net

11Control Systems and The Quest for Autonomy

RCL without Token & IC without Token

RCL Disabled (without Token) IC Disabled (without Token)

RCL-IC Console Petri Net

12Control Systems and The Quest for Autonomy

RCL with Token & IC without Token

RCL Enabled (with Token) IC Disabled (without Token)

RCL-IC Console Petri Net

13Control Systems and The Quest for Autonomy

RCL without Token & IC without Token

RCL Disabled (without Token) IC Disabled (without Token)

RCL-IC Console Petri Net

14Control Systems and The Quest for Autonomy

RCL without Token & IC with Token

RCL Disabled (without Token) IC Ready to Enable All (with Token)